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In the first installment of this three-part series we explored the reasons why cannabis breeders should adopt a strong IP strategy sooner rather than later and looked briefly at the types of IP that those breeders and growers should be considering. In this second installment, we will examine in more detail patent protection for innovative new varieties of cannabis and how one can use that patent protection to further their business objectives.

What is a patent and what do I do with one?

A patent is a right granted by the government to protect a new and useful invention. Importantly, a patent gives its owner an exclusionary right as opposed to a right to do something – the patent owner has the right to exclude others from making, using, selling, offering to sell, or importing the invention (or, for a plant, any of its plant parts) for the term of the patent, which is 20 years for the types of patents that can be used to protect new cannabis varieties.

Because it is an exclusionary right, there are essentially two things that a patent owner can use a patent to do: 1) disallow anyone else from producing and selling that variety (or any of its parts) so that the patent owner is able to capture all of the sales for that variety, or 2) use license contracts to allow other growers to grow the variety while paying royalties back to the patent holder. The latter option can often be beneficial because it can greatly expand production of the variety by licensing to multiple growers. However, this does require some oversight on the part of the patent holder to make sure that the product those growers are producing is high quality –growers who produce poor quality product can hurt the existing brand. Cannabis breeders should consider these options up front when formulating their IP strategy.

Which type of patent should I use to protect my new variety?

As a further consideration, there are two different types of patents that can be used to protect new plant varieties and there are multiple factors to consider when determining which one to pursue.

U.S. Plant Patents are a special type of intellectual property that is used solely for the protection of asexually/vegetatively reproduced plant varieties. Traditionally, plant patents have been used to protect new varieties of ornamental and fruit trees and shrubs, such as a new variety of rose bush or a new variety of apple tree, such as the ‘Honeycrisp’ apple tree, patented in 1990. This type of patent has recently been used to protect a new cannabis variety called ‘Ecuadorian sativa’, while several other cannabis varieties, ‘Midnight’, ‘Erez’, and ‘Avidekel’ varieties are awaiting plant patent approval.

On the other hand, a “utility patent” can be used for new “compositions” (e.g., a new type of grow light) or new types of “methods” (e.g., a new method of extracting compounds from cannabis or a new method of growing cannabis to produce higher THC content). This type of patent can also be used to protect a new plant variety so long as the applicant can demonstrate that the variety is novel and not obvious over what was already known in the art. To date, two utility patents have been issued to protect cannabis varieties that exhibit certain cannabinoid and terpene profiles (U.S. Patent Nos. 9,095,554 and 9,370,164), and other similar utility patent applications are also pending (e.g., U.S. Patent Pub. No. 2014/0298511).

One of the main determining factors in deciding which type of patent to pursue is the nature of the invention. Growers and breeders will likely want to seek a plant patent if they have developed a new variety of cannabis plant: 1) which was made using simple breeding techniques, 2) which can be stably reproduced in an asexual manner (such as by cuttings and cloning), and 3) which is different from its parents and certain other strains on the market, but not completely distinct from everything that already exists. On the other hand, growers and breeders may want to consider a utility patent if they have developed a new variety of cannabis plant: 1) which has unique features in comparison to everything else that exists today (such as a unique disease resistance or chemical makeup), 2) which has unique features that can be demonstrated by some sort of biological or chemical test, and 3) that can be reproduced either asexually or by seed. It is also important to keep in mind that these two routes are not mutually exclusive – one could apply for both types of patent if the variety satisfies the criteria for both.

Though there are numerous similarities between the processes for obtaining both types of patents, there are also clear differences that should be taken into consideration when making the decision about which type of patent to seek. For instance, the grant rate for plant patents is much higher, meaning there is a higher likelihood that the plant patent application will eventually be granted compared to a utility patent application. Further, plant patent applications typically move quicker through the Patent Office, frequently being granted in approximately 18 months, while utility patent applications typically take two to four years (or more) to issue.

Another factor that should be considered is cost. Because a plant patent application is much simpler to prepare and typically moves through the Patent Office more swiftly, the cost for obtaining a plant patent is generally significantly lower than for a utility patent.

Determining which type of patent to pursue requires consideration of numerous factors. However, it is important to keep in mind that, regardless of which type of patent a grower or breeder seeks, there are certain time limitations that can impact the right to obtain a patent. For example, patent protection can only be sought if the variety to be patented has not been sold, offered for sale, or otherwise made publicly available more than one year before the patent application is filed. After that time, the invention becomes part of the “public domain.” So if a breeder chooses to wait to seek patent protection for a new variety, they risk losing the ability to ever get that protection.

Clearly, growers and breeders have to weigh several options when formulating a patent strategy, including what type of patent to pursue and what to do with the patent once they obtain it. Thinking through these issues early on allows the cannabis breeder an opportunity to formulate a strategy that is most beneficial in furthering their business objectives. Additionally, regardless of the type of patent strategy used, it is often helpful to combine it with trademark and branding strategy, which allows the business to utilize a more comprehensive approach to IP for their innovative strains. The third installment of this series will focus on trademarks for cannabis products and some unique issues that facing the cannabis industry today.

Legal disclaimer: The material provided in this article is for informational purposes only and not for the purpose of providing legal advice. The opinions expressed herein are the opinions of the individual author and may not reflect the opinions of the firm or any individual attorney. The provision of this information and your receipt and/or use of it (1) is not provided in the course of and does not create or constitute an attorney-client relationship, (2) is not intended as a solicitation, (3) is not intended to convey or constitute legal advice, and (4) is not a substitute for obtaining legal advice from a qualified attorney. You should not act upon any such information without first seeking qualified professional counsel on your specific matter.

This three-part series will provide an in-depth look at intellectual property (IP) protection that is available for innovative and new varieties of cannabis. In this first installment, we will examine the reasons why cannabis breeders should adopt a strong IP strategy and look briefly at the types of IP that they should be considering. In the second and third pieces, we will look at the types of IP protection that can be used to protect innovative cannabis varieties and the unique IP issues the cannabis industry faces right now. Taken together, these articles will provide insight into IP strategies that cannabis breeders and growers can employ today to help prepare for the day that cannabis becomes legal nationally.

Why should I use IP to protect my cannabis varieties?

First and foremost, as the cannabis industry continues to move from a small, tight-knit community of breeders and growers into a ‘big-business’ industry, IP is the only way for breeders to protect the investment of time, energy and money that they put into developing new and innovative strains of cannabis. At a recent cannabis growing conference, one sentiment felt among numerous breeders was a feeling of frustration– stemming from the fact that they had spent many years developing new varieties of cannabis and, now that the industry is exploding, they are not getting recognition for all that effort. The way to avoid this issue is to protect novel varieties with IP to ensure that you are given proper credit for all of your hard work.

Moreover, an examination of industries that have strong similarities to the cannabis industry, such as other plant-based industries and ‘vice’ industries, provides compelling evidence that IP will become a main driving force in the cannabis industry as it continues to mature. For example, the fruit and hops industries have been relying upon strong plant patent and trademark protection for many years. The extremely popular Honeycrisp apple is a patented variety and the Amarillo hops variety (officially called ‘VGXP01’) is protected by both a U.S. Plant Patent and a federally registered trademark. Similarly, the alcohol and tobacco industries rely upon strong trademark and branding strategies, with many consumers being extremely brand-particular.

Additionally, there is strong evidence that the cannabis industry is primed for intellectual property protection. Since long before cannabis was legalized, consumers who were buying cannabis on the black market often sought out a particular variety from their dealer, something that becomes more prevalent as the industry continues to mature.

Why is now the time to think about IP?

First, the relevant governmental bodies have now provided some clarity as to the types of IP protection that can, and cannot be obtained for cannabis. For example, it is now clear that the U.S. Patent and Trademark Office (USPTO) will issue patents that cover new cannabis plant varieties and related innovations, such as novel growing methods. In fact, the first U.S. Plant Patent that covers a novel cannabis strain, called ‘Ecuadorian Sativa’, issued in late 2016.

Similarly, though federal trademark registration is not currently available if the product being protected is a cannabis product that is illegal under federal law. Federal trademark registration may be available to protect products related to the cannabis industry that are not themselves federally illegal (e.g., grow lights, fertilizer, etc.). Many states with legalized cannabis will grant state trademark registrations for cannabis products regardless of whether the products are viewed as illegal under current federal law. With this increased clarity, companies can now begin to formulate a comprehensive IP strategy that ties together the various types of IP protection.

Additionally, cannabis breeders and growers should look to adopt an IP strategy now because there are certain time bars that exist that may result in loss of rights if they wait. For example, as we will discuss in Part 2 of the series, patent protection can only be sought if the variety to be patented was not sold, offered for sale, or otherwise made publicly available more than one year before the patent application is filed. So if a breeder chooses to wait to seek patent protection for a new variety, the ability to ever get that protection may be lost.

The bottom line is that, to solidify their place in the market, cannabis breeders and growers should be formulating an IP strategy sooner rather than later. Those forward-thinking growers and breeders that adopt a comprehensive IP strategy up front will gain a distinct competitive advantage over competing growers and breeders down the road – an advantage that will become even more important if and when large corporations begin to move into the cannabis space. Those companies that have strong brands in place will be better equipped to survive and thrive in the face of pressure from legal teams at larger companies.

The next two installments of this series will examine the specifics of the types of IP protection that can be sought and the unique issues that the cannabis industry faces with each of them.

Legal disclaimer: The material provided in this article is for informational purposes only and not for the purpose of providing legal advice. The opinions expressed herein are the opinions of the individual author and may not reflect the opinions of the firm or any individual attorney. The provision of this information and your receipt and/or use of it (1) is not provided in the course of and does not create or constitute an attorney-client relationship, (2) is not intended as a solicitation, (3) is not intended to convey or constitute legal advice, and (4) is not a substitute for obtaining legal advice from a qualified attorney. You should not act upon any such information without first seeking qualified professional counsel on your specific matter.

Dr. Hope Jones, chief scientific officer of C4 Laboratories, believes there are a number of opportunities for cannabis growers to scale their cultivation up with micropropagation. In her presentation at the CannaGrow conference recently, Dr. Jones discussed the applications and advantages of tissue culture techniques in cannabis growing.

Dr. Hope Jones, chief scientific officer at C4 Labs

Dr. Jones’ work in large-scale plant production led her to the University of Arizona Controlled Environment Agriculture Center (CEAC) where she worked to propagate a particularly difficult plant to grow- a native orchid species- using tissue culture techniques. With that experience in tissue culture, hydroponics and controlled environments, she took a position at the Kennedy Space Center working for NASA where she developed technologies and protocols to grow crops for space missions. “I started with strawberry TC [tissue culture], because of the shelf life & weight compared with potted plants, plus you can’t really ‘water’ plants in space- at least not in the traditional way,” says Dr. Jones. “Strawberries pack a lot of antioxidants. Foods high in antioxidants, I argued, could boost internal protection of astronauts from high levels of cosmic radiation that they are exposed to in space.” That research led to a focus on cancer biology and a Ph.D. in molecular & cellular biology and plant sciences, culminating in her introduction to the cannabis industry and now with C4 Labs in Arizona.

Working with tissue culture since 2003, Dr. Jones is familiar with this technology that is fairly new to cannabis, but has been around for decades now and is widely used in the horticulture industry today. For example, Phytelligence is an agricultural biotechnology company using genetic analysis and tissue culture to help food crop growers increase speed to harvest, screen for diseases, store genetic material and secure intellectual property. “Big horticulture does this very well,” says Dr. Jones. “There are many companies generating millions of clones per year.” The Department of Plant Sciences Pomology Program at the Davis campus of the University of California uses tissue culture with the Foundation Plant Services (FPS) to eliminate viruses and pathogens, while breeding unique cultivars of strawberries.

A large tissue culture facility run in the Sacramento area that produces millions of nut and fruit trees clones a year.

First, let’s define some terms. Tissue culture is a propagation tool where the cultivator would grow tissue or cells outside of the plant itself, commonly referred to as micropropagation. “Micropropagation produces new plants via the cloning of plant tissue samples on a very small scale, and I mean very small,” says Dr. Jones. “While the tissue used in micropropagation is small, the scale of production can be huge.” Micropropagation allows a cultivator to grow a clone from just a leaf, bud, root segment or even just a few cells collected from a mother plant, according to Dr. Jones.

The science behind growing plants from just a few cells relies on a characteristic of plant cells called totipotency. “Totipotency refers to a cell’s ability to divide and differentiate, eventually regenerating a whole new organism,” says Dr. Jones. “Plant cells are unique in that fully differentiated, specialized cells can be induced to dedifferentiate, reverting back to a ‘stem cell’-like state, capable of developing into any cell type.”

Cannabis growers already utilize the properties of totipotency in cloning, according to Dr. Jones. “When cloning from a mother plant, stem cuttings are taken from the mother, dipped into rooting hormone and two to five days later healthy roots show up,” says Dr. Jones. “That stem tissue dedifferentiates and specializes into new root cells. In this case, we humans helped the process of totipotency and dedifferentiation along using a rooting hormone to ‘steer’ the type of growth needed.” Dr. Jones is helping cannabis growers use tissue culture as a new way to generate clones, instead of or in addition to using mother plants.

With cannabis micropropagation, the same principles still apply, just on a much smaller scale and with greater precision. “In this case, very small tissue samples (called explants) are sterilized and placed into specialized media vessels containing food, nutrients, and hormones,” says Dr. Jones. “Just like with cuttings, the hormones in the TC media induce specific types of growth over time, helping to steer explant growth to form all the organs necessary to regenerate a whole new plant.”

Having existed for decades, but still so new to cannabis, tissue culture is an effective propagation tool for advanced breeders or growers looking to scale up. In the next part of this series, we will discuss some of issues with mother plants and advantages of tissue culture to consider. In Part 2 we will delve into topics like sterility, genetic reboot, viral infection and pathogen protection.

DNA stores information about how to build an organism. Just as a series of 0’s and 1’s represents digital data, DNA data is represented by four letters (A, C, G and T), which inherently allows DNA to store more information per unit (Figure 1).

Figure 1

The amount of DNA required to build a human is mind-boggling. The human genome has 3.2 billion A’s, C’s, G’s, or T’s, (called nucleotides). Cannabis has 820 million nucleotides. This is true for every cell in the organism. The DNA from a single human cell when spread out would stretch six feet long. A cell is not visible to the naked eye, yet it contains a microscopic thread of DNA six feet long! If you put all the DNA molecules in your body end to end, the DNA would reach from the Earth to the Sun.

DNA is common in all living things, and all living things are related through DNA. Humans and plants share 50% of their genes. In humans, 99.9% of the DNA is identical, thus just 0.1% of DNA differences accounts for all of the variation observed in humans. Cannabis, as a species, is more variable with approximately 1% of the DNA being different among strains. DNA is a super efficient and reliable information storage system. However, mistakes (mutations) do occur and while infrequent, these mutations account for all the differences observed within a species and is called natural genetic variation. Variation within the genomes of a species can help the species survive in unfavorable conditions (evolution) and is also the source of differences in traits, which is the material that is required for successful breeding.

Natural Genetic Variation

DNA mutations occur in every generation and these changes will be different in each individual creating natural genetic variation. Mutations (or more accurately referred to as DNA changes) will be inherited by offspring and will persist in the population if the offspring reproduce.

Figure 2

DNA differences maintain diversity in the gene pool, allowing organisms to respond to new environments (migration) or environmental changes (adaptation). The two most commonly described cannabis families are Indicas and Sativas. Indicas, being from cooler temperate regions, have wide leaves allowing the maximum capture of light during the shorter growing season. Sativas, being equatorial, have smaller leaves, which may be an advantage for such things as powdery mildew in a humid environment. Figure 2 shows the enormous amount of natural variation in leaves for one species with a worldwide population (Arabidopsis thaliana).

A DNA change that occurred a long time ago will be more useful to divide people/plants into different groups. For example, there are ancient DNA changes that differentiate humans originating from Europe or Asia. Other newer DNA changes allow us to further divide Europeans into those originating from Northern versus Southern Europe. Thus, different DNA changes have different values for determining relatedness or ancestry, yet every DNA change provides some information for determining heredity.

Figure 3

Family Trees

By comparing DNA changes among different strains, we can measure the relatedness between strains. For example, if strain A has a DNA change indicative of Kush ancestry and strain B has a DNA change indicative of hemp ancestry, we can assign strains to branches of the cannabis family tree comprised of strains that contain similar DNA changes. Figure 3 shows 184 strains that have been characterized for these changes, and the position of each strain is based on its shared DNA with neighboring strains. The two best-defined families of cannabis are hemp (blue) and kush (black). Strains within a family are more closely related. Strains in separate families, such as kush and hemp, are more distantly related.

Editor’s Note: This is the first installment in a series of articles focused on answering common questions regarding cannabis genetics. If you have questions regarding cannabis genetics, or wish to speak more about the topic please post in the comments section below. The next installment will delve into the THC synthase, gene discovery and manipulation and mapping chromosomes.

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